1.Survival Nomograms after Curative Neoadjuvant Chemotherapy and Radical Surgery for Stage IB2-IIIB Cervical Cancer.
Claudia MARCHETTI ; Francesca DE FELICE ; Anna DI PINTO ; Alessia ROMITO ; Angela MUSELLA ; Innocenza PALAIA ; Marco MONTI ; Vincenzo TOMBOLIN ; Ludovico MUZII ; PierLuigi BENEDETTI PANICI
Cancer Research and Treatment 2018;50(3):768-776
PURPOSE: The purpose of this study was to develop nomograms for predicting the probability of overall survival (OS) and progression-free survival (PFS) in locally advanced cervical cancer treated with neoadjuvant chemotherapy and radical surgery. MATERIALS AND METHODS: Nomograms to predict the 5-year OS rates and the 2-year PFS rates were constructed. Calibration plots were constructed, and concordance indices were calculated. Evaluated variableswere body mass index, age, tumor size, tumor histology, grading, lymphovascular space invasion, positive parametria, and positive lymph nodes. RESULTS: In total 245 patients with locally advanced cervical cancer who underwent neoadjuvant chemotherapy and radical surgery were included for the construction of the nomogram. The 5-year OS and PFS were 72.6% and 66%, respectively. Tumor size, grading, and parametria status affected the rate of OS, whereas tumor size and positive parametria were the main independent PFS prognostic factors. CONCLUSION: We constructed a nomogram based on clinicopathological features in order to predict 2-year PFS and 5-year OS in locally advanced cervical cancer primarily treated with neoadjuvant chemotherapy followed by radical surgery. This tool might be particularly helpful for assisting in the follow-up of cervical cancer patients who have not undergone concurrent chemoradiotherapy.
Body Mass Index
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Calibration
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Chemoradiotherapy
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Disease-Free Survival
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Drug Therapy*
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Follow-Up Studies
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Humans
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Lymph Nodes
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Nomograms*
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Recurrence
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Uterine Cervical Neoplasms*
2.Comparison of Anogenital Distance and Correlation with Vulvo-vaginal Atrophy: A Pilot Study on Premenopausal and Postmenopausal Women
Lavinia DOMENICI ; Angela MUSELLA ; Carlotta BRACCHI ; Francesca LECCE ; Michele Carlo SCHIAVI ; Vanessa COLAGIOVANNI ; Violante DI DONATO ; Claudia MARCHETTI ; Federica TOMAO ; Innocenza PALAIA ; Ludovico MUZII ; Pierluigi BENEDETTI PANICI
Journal of Menopausal Medicine 2018;24(2):108-112
OBJECTIVES: Anogenital distance (AGD) represents the space between labia posterior commissure and anus. This was pilot study to investigate how menopause and so lack of oestrogens affects AGD. METHODS: A total of 109 patients were enrolled. AGD was measured in lithotomy position using sterile paper ruler. Anogenital index (AGI) was used to control 2 variables of height and weight (body mass index, kg/m2). Vaginal health index (VHI) was used to evaluate vaginal wellness. Female sexual function index (FSFI) questionnaire was administered to all women to evaluate the impact of menopause on their sexual function. RESULTS: AGD (30.87 ± 2.98 vs. 17.57 ± 2.18; P = 0.0001) and AGI (1.40 ± 0.21 vs. 0.70 ± 0.15; P = 0.0001) were both significantly lower in the postmenopausal group. Postmenopausal women were affected by vulvovaginal atrophy (VVA) significantly. Thus, VHI scores were dramatically worse in postmenopausal group (23.95 ± 1.28 vs. 10.75 ± 3.41; P = 0.0001) as well as FSFI results (32.68 ± 2.25 vs. 19.78 ± 5.46; P = 0.0001). CONCLUSIONS: This study confirms that AGD in post-menopausal women was significantly shorter than AGD in premenopausal women, correlating with an increase of VVA and sexual impairment. Changes of AGD and AGI demonstrated to predict hormonal changes that may occur after menopause.
Anal Canal
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Atrophy
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Female
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Humans
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Menopause
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Pilot Projects
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Sexuality
3.The age-adjusted Charlson comorbidity index as a predictor of survival in surgically treated vulvar cancer patients.
Violante DI DONATO ; Zoe PAGE ; Carlotta BRACCHI ; Federica TOMAO ; Angela MUSELLA ; Giorgia PERNIOLA ; Pierluigi Benedetti PANICI
Journal of Gynecologic Oncology 2019;30(1):e6-
OBJECTIVE: To evaluate the impact of age-adjusted Charlson comorbidity index (ACCI) in predicting disease-free survival (DFS), overall survival (OS), and cancer-specific survival (CSS) among surgically treated patients with vulvar carcinoma. The secondary aim is to evaluate its impact as a predictor of the pattern of recurrence. METHODS: We retrospectively evaluated data of patients that underwent surgical treatment for vulvar cancer from 1998 to 2016. ACCI at the time of primary surgery was evaluated and patients were classified as low (ACCI 0–1), intermediate (ACCI 2–3), and high risk (>3). DFS, OS and CSS were analyzed using the Kaplan-Meir and the Cox proportional hazard models. Logistic regression model was used to assess predictors of distant and local recurrence. RESULTS: Seventy-eight patients were included in the study. Twelve were classified as low, 36 as intermediate, and 30 as high risk according to their ACCI. Using multivariate analysis, ACCI class was an independent predictor of worse DFS (hazard ratio [HR]=3.04; 95% confidence interval [CI]=1.54–5.99; p < 0.001), OS (HR=5.25; 95% CI=1.63–16.89; p=0.005) and CSS (HR=3.79; 95% CI=1.13–12.78; p=0.03). Positive nodal status (odds ratio=8.46; 95% CI=2.13–33.58; p=0.002) was the only parameter correlated with distant recurrence at logistic regression. CONCLUSION: ACCI could be a useful tool in predicting prognosis in surgically treated vulvar cancer patients. Prospective multicenter trials assessing the role of ACCI in vulvar cancer patients are warranted.
Aged
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Comorbidity*
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Disease-Free Survival
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Humans
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Logistic Models
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Multicenter Studies as Topic
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Multivariate Analysis
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Prognosis
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Proportional Hazards Models
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Prospective Studies
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Recurrence
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Retrospective Studies
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Vulvar Neoplasms*
4.Immunotherapy in endometrial cancer: new scenarios on the horizon
Chiara DI TUCCI ; Carmela CAPONE ; Giulia GALATI ; Valentina IACOBELLI ; Michele C SCHIAVI ; Violante DI DONATO ; Ludovico MUZII ; Pierluigi Benedetti PANICI
Journal of Gynecologic Oncology 2019;30(3):e46-
This extensive review summarizes clinical evidence on immunotherapy and targeted therapy currently available for endometrial cancer (EC) and reports the results of the clinical trials and ongoing studies. The research was carried out collecting preclinical and clinical findings using keywords such as immune environment, tumor infiltrating lymphocytes, programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) expression, immune checkpoint inhibitors, anti-PD-1/PD-L1 antibodies and others' on PubMed. Finally, we looked for the ongoing immunotherapy trials on ClinicalTrials.gov. EC is the fourth most common malignancy in women in developed countries. Despite medical and surgical treatments, survival has not improved in the last decade and death rates have increased for uterine cancer in women. Therefore, identification of clinically significant prognostic risk factors and formulation of new rational therapeutic regimens have great significance for enhancing the survival rate and improving the outcome in patients with advanced or metastatic disease. The identification of genetic alterations, including somatic mutations and microsatellite instability, and the definition of intracellular signaling pathways alterations that have a major role in in tumorigenesis is leading to the development of new therapeutic options for immunotherapy and targeted therapy.
Antibodies
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Biological Therapy
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Carcinogenesis
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Developed Countries
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Endometrial Neoplasms
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Female
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Humans
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Immunotherapy
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Lymphocytes, Tumor-Infiltrating
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Microsatellite Instability
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Molecular Targeted Therapy
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Mortality
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Risk Factors
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Survival Rate
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Uterine Neoplasms
5.Fertility-sparing surgery for women with stage I cervical cancer of 4 cm or larger: a systematic review
Violante Di DONATO ; Giuseppe CARUSO ; Carolina Maria SASSU ; Giusi SANTANGELO ; Giorgio BOGANI ; Francesco PLOTTI ; Flavia SORBI ; Giorgia PERNIOLA ; Innocenza PALAIA ; Gianluca TERRIN ; Roberto ANGIOLI ; Pierluigi Benedetti PANICI ; Ludovico MUZII
Journal of Gynecologic Oncology 2021;32(6):e83-
Objective:
To investigate current evidence on oncological, fertility and obstetric outcomes of patients with stage I cervical cancer of 4 cm or larger undergoing fertility-sparing surgery (FSS).
Methods:
Systematic review of studies including women affected by stage I cervical cancer ≥4 cm who underwent FSS. Main outcome measures: disease-free survival (DFS), overall survival (OS), pregnancy rate, live birth rate, premature delivery rate.
Results:
Fifteen studies met all eligibility criteria for this systematic review, involving 48 patients affected by cervical cancer ≥4 cm who completed FSS. Three patients (6.3%) experienced a recurrence and one of them (2.1%) died of disease. The 5-year DFS rate was 92.4%. The 5-year OS rate was 97.6%. A significantly shorter 5-year DFS was reported for high-risk patients (G3, non-squamous histotype, diameter ≥5 cm) compared with low-risk (74.7% vs. 100%; log-rank test, p=0.024). Data about fertility outcomes were available for 12 patients. Five patients out of 12 (41.7%) attempted to conceive with an estimated pregnancy rate of 80%, a live birth rate of 83.3% and a premature delivery rate of 20%.
Conclusion
Women with high tumor grade, aggressive histology and tumor size ≥5 cm have a higher risk of recurrence. Oncologic outcomes are encouraging among low-risk patients; however, the lack of high-quality studies makes it difficult to draw any firm conclusions. Prospective multicentric clinical trials with a proper selection of inclusion/exclusion criteria should be conducted in women with low-risk factors, strong desire to preserve their fertility and high likelihood to conceive.
6.Systematic lymph node dissection during interval debulking surgery for advanced epithelial ovarian cancer: a systematic review and meta-analysis
Giuseppe CARUSO ; Innocenza PALAIA ; Giorgio BOGANI ; Federica TOMAO ; Giorgia PERNIOLA ; Pierluigi Benedetti PANICI ; Ludovico MUZII ; Violante Di DONATO
Journal of Gynecologic Oncology 2022;33(5):e69-
Objective:
To evaluate the efficacy and safety of systematic lymph node dissection (SyLND) at the time of interval debulking surgery (IDS) for advanced epithelial ovarian cancer (AEOC).
Methods:
Systematic literature review of studies including AEOC patients undergoing SyLND versus selective lymph node dissection (SeLND) or no lymph node dissection (NoLND) after neoadjuvant chemotherapy (NACT). Primary endpoints included progression-free survival (PFS) and overall survival (OS). Secondary endpoints included severe postoperative complications, lymphocele, lymphedema, blood loss, blood transfusions, operative time, and hospital stay.
Results:
Nine retrospective studies met the eligibility criteria, involving a total of 1,660 patients: 827 (49.8%) SyLND, 490 (29.5%) SeLND, and 343 (20.7%) NoLND. The pooled estimated hazard ratios (HR) for PFS and OS were, respectively, 0.88 (95% confidence interval [CI]=0.65–1.20; p=0.43) and 0.80 (95% CI=0.50–1.30; p=0.37). The pooled estimated odds ratios (ORs) for severe postoperative complications, lymphocele, lymphedema, and blood transfusions were, respectively, 1.83 (95% CI=1.19–2.82; p=0.006), 3.38 (95% CI=1.71–6.70; p<0.001), 7.23 (95% CI=3.40–15.36; p<0.0001), and 1.22 (95% CI=0.50–2.96; p=0.67).
Conclusion
Despite the heterogeneity in the study designs, SyLND after NACT failed to demonstrate a significant improvement in PFS and OS and resulted in a higher risk of severe postoperative complications.
7.Impact of COVID-19 in gynecologic oncology: a Nationwide Italian Survey of the SIGO and MITO groups
Giorgio BOGANI ; Giovanni APOLONE ; Antonino DITTO ; Giovanni SCAMBIA ; Pierluigi Benedetti PANICI ; Roberto ANGIOLI ; Sandro PIGNATA ; Stefano GREGGI ; Paolo SCOLLO ; Mezzanzanica DELIA ; Massimo FRANCHI ; Fabio MARTINELLI ; Mauro SIGNORELLI ; Salvatore LOPEZ ; Violante Di DONATO ; Giorgio VALABREGA ; Gabriella FERRANDINA ; Innocenza PALAIA ; Alice BERGAMINI ; Luca BOCCIOLONE ; Antonella SAVARESE ; Fabio GHEZZI ; Jvan CASARIN ; Ciro PINELLI ; Vito TROJANO ; Vito CHIANTERA ; Giorgio GIORDA ; Francesco SOPRACORDEVOLE ; Mario MALZONI ; Giovanna SALERNO ; Enrico SARTORI ; Antonia TESTA ; Gianfranco ZANNONI ; Fulvio ZULLO ; Enrico VIZZA ; Giuseppe TROJANO ; Antonio CHIANTERA ; Francesco RASPAGLIESI
Journal of Gynecologic Oncology 2020;31(6):e92-
Objective:
Coronavirus disease 2019 (COVID-19) has caused rapid and drastic changes in cancer management. The Italian Society of Gynecology and Obstetrics (SIGO), and the Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO) promoted a national survey aiming to evaluate the impact of COVID-19 on clinical activity of gynecologist oncologists and to assess the implementation of containment measures against COVID-19 diffusion.
Methods:
The survey consisted of a self-administered, anonymous, online questionnaire. Thesurvey was sent via email to all the members of the SIGO, and MITO groups on April 7, 2020, and was closed on April 20, 2020.
Results:
Overall, 604 participants completed the questionnaire with a response-rate of 70%. The results of this survey suggest that gynecologic oncology units had set a proactive approach to COVID-19 outbreak. Triage methods were adopted in order to minimize in-hospital diffusion of COVID-19. Only 38% of gynecologic surgeons were concerned about COVID-19 outbreak. Although 73% of the participants stated that COVID-19 has not significantly modified their everyday practice, 21% declared a decrease of the use of laparoscopy in favor of open surgery (19%). However, less than 50% of surgeons adopted specific protection against COVID-19. Additionally, responders suggested to delay cancer treatment (10%–15%), and to perform less radical surgical procedures (20%–25%) during COVID-19 pandemic.
Conclusions
National guidelines should be implemented to further promote the safety of patients and health care providers. International cooperation is of paramount importance, as heavily affected nations can serve as an example to find out ways to safely preserve clinical activity during the COVID-19 outbreak.